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Director of Quality

Executive Summary & Candidate Overview
  • Demonstrated expertise in quality management spanning pharmaceuticals, biologics, drug manufacturing, clinical trials, and clinical laboratory oversight.

  • Known for her positive attitude and ability to inspire others, with a knack for managing complex problems with creative and articulate solutions.

  • Valuable contributor as an expert in regulatory trends and GxP/EMA guidance, providing assistance to executive teams and various departments.

Accomplishments and Key Performance Indicators (KPIs)
  • Led global quality initiatives for internal cell therapy drug manufacturing facilities, ensuring compliance with FDA/EU (EMA) GxP regulations.

  • Developed and improved the quality management system (QMS) for a new manufacturing facility, covering deviation management, CAPA, change control, audits, and documentation.

  • Provided strategic and tactical leadership for the design, construction, commissioning, and qualification of a new vector manufacturing facility in Illinois.

  • Played a pivotal role in the first technology transfer of hyperstacked lentiviral manufacturing and ensured compliance with clean room qualification and equipment validation.

  • Authored and reviewed SOPs, policies, and job descriptions, interpreting FDA and EMA regulations for compliance.

  • Managed a $1M budget and implemented quality agreements for manufacturing cell/gene therapy products for multiple biotechnology companies.

Location and Travel
  • Open to: On-Site, Hybrid, and Remote Roles.

  • Remote Roles: Willing to consider remote opportunities based on specific position requirements.

  • Compensation Seeking: Open to discussing compensation details upon scheduling a meeting.

  • Position Seeking: Seeking Director-level roles in Validation or Technical Operations within the pharmaceutical industry.

Work Experience
  • Director, Quality at Bristol Myers Squibb

    • Global quality leadership for internal cell therapy drug manufacturing facilities.

  • Quality Director, Cell Therapy at Moffitt Cancer Center

    • Leadership and strategic guidance for continuous compliance with FDA, FACT-JACIE, ISO, ICH, JCAHO, and CLIA regulations.

  • Director, Quality – Divisional at LabCorp

    • Oversight of 30 clinical laboratories in nine different states, ensuring adherence to CLIA guidelines and regulations.

  • Quality & Safety Manager – Regional at LabCorp

    • Continuous improvement initiatives for laboratories and patient service centers, preparation and hosting of external audits, and management of audit findings.

  • Medical Technologist at Westat

    • Medical technologist role with NHANES, ensuring compliance with CLIA guidelines and regulations.

  • Quality Assurance Coordinator at CryoCell International

    • Quality assurance role in a cord blood and research facility, overseeing cord blood stem cell batch record data and participating in facility accreditations.

  • Medical Technologist at DSI Laboratories

    • Medical technologist and phlebotomist role in a pediatric center, conducting laboratory assays and ensuring quality control and assurance procedures.

  • Master of Science in Health Administration from Ohio Dominican University

  • Bachelor of Science in Clinical Laboratory Science from Florida Gulf Coast University

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Background Check (Upon Request)
Team & Role Fit Analysis (Upon Request)
Plan to Meet Objectives (Upon Request)
Relationships & Financials (Upon Request)

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